Animal Research and Testing
Scientific research involving animals helps us to learn more about the diseases that affect both humans and animals and we can apply that understanding to develop new medicines. Some of the processes involved in disease can only be studied in a living organism and animals are used when there is no alternative and where it is impractical or unethical to study in humans. Animals can act as models to test the effectiveness (i.e to demonstrate potential beneficial effects) as well as the safety (i.e. to demonstrate potential harmful effects) of a new medicine ahead of clinical trials in humans.
In the UK, animal research and testing is tightly regulated by the Animals (Scientific Procedures) Act 1986 (ASPA) which is implemented by the Home Office in England, Scotland and Wales. The original act related to the 1986 EU Directive 86/609/EEC which was updated and replaced by EU Directive 2010/63/EU; the revised legislation came into force in January 2013. Paracelsis conducts animal research under a Procedure Project Licence (PPL) and any member of staff who carries out procedures in animals will have received the necessary training and hold a Procedure Individual Licence (PIL). The external facilities (Test Facilities) where Paracelsis conducts these studies will have the necessary Establishment Licence (EL) authority to permit studies in animals to be conducted at its facilities. Paracelsis’ work is subject to independent approval by the facilities Animal Welfare and Ethical Review Board (AWERB), prior to submission to the Home Office Inspectorate, and AWERB is instrumental in ensuring that any work to be conducted at its facilities is scientifically justified and strictly adheres to the principles of the 3Rs (Replacement, Reduction and Refinement) as required under ASPA.
- R&D activities and lab studies must avoid using animals wherever possible.
- Any use of animals must be scientifically justified and there must be clear reasons why there are no realistic alternatives.
- Paracelsis will only conduct scientific investigations involving animals which are well designed, and which are likely to provide new information on important questions relevant to human and/or animal health.
- Animal experiments must use the simplest possible, or least sentient, species of animal.
- Ethical issues associated with the keeping of animals in captivity; the procedures to be carried out, especially regarding the potential to cause distress or pain; and the killing of animals must be considered.
- The principles of the 3Rs must be adhered to such that:
– Non-animal alternatives must be used wherever possible (Replacement).
– Experiments must be appropriately designed and use the smallest number of animals to answer the scientific questions posed (Reduction).
– Every practical step must be taken to avoid distress, pain or suffering (Refinement).
- All staff involved in animal research and testing, and in the breeding, housing and care of animals, must be properly trained and supervised.
- By law, Paracelsis will ensure that the necessary PPL, PIL and EL authority is in place before starting any work involving animals.
- Paracelsis will seek to develop and disseminate techniques that replace, reduce, or refine, animal experiments.
- Where lab studies/R&D activities involving the use of animal are conducted outside of the UK, Paracelsis will ensure that standards there are consistent with standards in the UK.
- All work conducted by Paracelsis will be subject to independent monitoring by a Named Animal Care and Welfare Officer (NACWO), Named Veterinary Surgeon (NVS) and animal care staff at the Test Facility.